Serial Ultrasonographic Assessment of Optic Nerve Sheath Diameter in Adults Scheduled for Elective Abdominopelvic Laparoscopic Surgery under General Anaesthesia: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Optic Nerve Sheath Diameter
研究概览
简要总结
Summary:
Aim:
The aim of the study is to evaluate changes in optic nerve sheath diameter (ONSD) using ultrasound (USG) at specific time points during laparoscopic abdominopelvic surgeries under general anesthesia.
Primary Objectives:
-
Assess changes in ONSD with variations in intra-abdominal pressure (IAP) during laparoscopic surgeries.
-
Measure ONSD before induction of anesthesia (T1), after airway securing (T2), five minutes later (T3), after insufflation of pneumoperitoneum (T4), after exsufflation of pneumoperitoneum (T5), and after tracheal extubation (T6).
Secondary Objectives:
-
Compare ONSD measurements between patients intubated with endotracheal tube and those using a supraglottic airway device.
-
Ensure patients’ safety and monitor vital signs throughout the procedure.
Intervention Technique:
Patients will follow pre-operative fasting guidelines and receive standard pre-operative preparation. ONSD measurements will be taken using USG. Anesthesia induction will be done with appropriate medications, and airway secured with an endotracheal tube or supraglottic airway device. ONSD measurements will be taken at specific time points intraoperatively. General anesthesia will be maintained, and ONSD measurements will be repeated after key surgical steps. Abnormal ONSD measurements will prompt ophthalmological evaluation postoperatively.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Adults between the age of 18-70 years posted for elective abdominopelvic laparoscopic surgery.
- •b) ASA physical status I, II or III.
排除标准
- •a) Refusal to provide informed consent.
- •b) Patients with a history suggestive of glaucoma, any active ocular infection or any ocular injury.
- •c) Patients with history suggestive of any intra-cranial pathology.
- •d) Conversion of laparoscopic procedure into open surgery intra-operatively due to any reason.
结局指标
主要结局
Optic Nerve Sheath Diameter
时间窗: T1 - before induction | T2 – after intubation | T3 – before insufflation | T4 – after insufflation | T5 – after exsufflation | T6 – after extubation
次要结局
- Hemodynamic Parameter(T1 - before induction of anaesthesia (baseline).)
- ONSD changes in Patients intubated with endotracheal tube vs supraglottic airway device(T1 - before induction of anaesthesia (baseline).)
研究者
Omna Trivedi
All India Institute of Medical Sciences, Bathinda